Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Graft volumetric stability change
研究概览
简要总结
The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.
详细描述
This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation.
Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients ≥ 18 years old
- •In need of sinus augmentation utilizing lateral window sinus technique
- •Presence of bone height of < 8 mm
- •Patient has good oral hygiene (<40% plaque score)
- •Periodontally stable
- •Willingness to fulfill all study requirements
排除标准
- •Currently smoking > 10 cigarettes / day
- •Pregnant, expecting to become pregnant or lactating mothers
- •Uncontrolled Diabetes Mellitus (HbA1c >7)
- •Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections)
- •Current use of oral bisphosphonates
- •History of IV bisphosphonates use
- •Poor oral hygiene (plaque score >40% based on O'Leary plaque score)
- •Unmanageable Sinus perforations
- •Significant pathology in the region of interest that may compromise the procedure
结局指标
主要结局
Graft volumetric stability change
时间窗: CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material
CBCT will be the primary tool to evaluate the volumetric stability of the graft material used in the sinus augmentation procedure
次要结局
- Histomorphometric analysis(After 6 months of sinus augmentation procedure when the implant is placed)